Title: NOPR National Oncologic PET Registry
1NOPRNational Oncologic PET Registry
2Medicare Reimbursement for Oncologic PET (2005)
- Diagnosis, staging, and restaging of
- Non-small cell lung cancer Lymphoma
- Esophageal cancer Malignant melanoma
- Colorectal cancer Head and neck cancer
- Staging, restaging, and Rx monitoring of breast
cancer - Detection of TG/RAI thyroid cancer
- Staging of cervical cancer ( CT/MRI outside
pelvis) - All other cancers/indications
- National registry
3NOPR
- Is a CMS-approved
- Coverage with Evidence Development Program
- Developed for the November 2004 expansion by CMS
- All other cancers and indications except
- Breast cancer diagnosis and axillary staging
- Melanoma regional nodal staging
- All PET facilities can participate (for a fee)
- Requires timely Pre-PET and Post-PET information
- All data will be submitted to CMS
- Cases with patient and physician consent will be
used by the NOPR to assess change in intended
management
4NOPRNational Oncologic PET Registry
NOPRNational Oncologic PET Registry
Sponsored by
Advisor
Managed by
Endorsed by
5Objectives Goals
- Objectives
- Assess the effect of PET on referring physicians
plans of intended patient management - across a wide spectrum of cancer indications for
PET that are currently not covered by the
Medicare program, and - in relation to cancer-type, indication,
performance status, physicians role in
management, and type of PET. - Goal
- Acquire data that can be used to evaluate PET in
a manner that does not interfere with patient
clinical care and minimizes the burden to the
patient, PET center, and referring physician.
6Data Analysis and Expected Results
- Data analyzed by cancer type and indication
(reason for PET). - For the most frequent cancer indications, interim
analysis will be performed at N200 to refine
sample size estimates. - If the frequency of change in intended management
for a particular cancer indication is sufficient
to suggest benefit, data (along with summary of
published literature) will be provided to CMS
with request for coverage. - Eventual goal is to achieve broad coverage
through analysis of data across all cancers and
indications.
7Institutional Review Board (IRB) Approval
Subject Informed Consent
- Is this research? Yes, but only for the NOPR.
Individual PET facilities and referring
physicians are not engaged in research. - Is IRB approval needed? Yes. ACR IRB has
approved the NOPR. Individual PET facilities and
referring physicians do not need to obtain IRB
approval to participate. - All data will be sent to CMS. CMS is not engaged
in research. - Patients and referring physicians will be given
an IRB-approved information sheet and asked for
oral consent to have their data included in NOPR
research. - Only cases where both patient and physician give
consent will be included in the NOPR research
dataset.
8Patient Informational Sheet
Available at CancerPETregistry.org
- Available in English and Spanish
Referring Physician Information Sheet
- Also Sent with Post-PET Form to Referring
Physician
9HIPAA Requirements
- HIPAA requirements met through execution of a
Business Associates Agreement with the American
College of Radiology as an agent for the Academy
of Molecular Imaging and CMS.
10Participation Requirements - PET Facilities
- Any PET facility that is approved to bill CMS for
either technical or global charges can
participate in the NOPR. - Facilities are not required to have or obtain ACR
or ICANL accreditation.
Participation Requirements - Patients
- Medicare beneficiaries, including those with
Medicare HMO coverage, who are referred for
FDG-PET for essentially all oncologic indications
that are not currently reimbursable under
Medicare. - The Indications table lists the cancers and
indications that are and are not eligible for the
Registry. - Oral consent is necessary for inclusion in the
NOPR research dataset however, no consent is
necessary to submit data to NOPR that will be
sent to CMS.
11PET Facility Responsibilities
- Collect and enter all required data through the
NOPR Web site. - Patient must be registered within 14 days of the
PET scan date - Give patient the Patient Information Sheet
- Pre-PET Form must be entered by midnight of the
PET scan date - PET Completion Form must be entered within 14
days of case registration - The PET Report Post-PET forms must be entered
within 30 days of scan - PET facility is eligible to bill CMS when all
required data are received at NOPR Operations
Office.
Referring Physician Responsibilities
- Complete Pre-PET Form (5 questions) and return it
to PET Facility prior to PET scan. - Complete Post-PET Form (4 - 7 questions) and
return it to PET Facility within 30 days of PET
scan. - Pre- and Post-PET forms can be returned to the
PET facility via FAX, mail, or hand delivery.
12Ineligible Indications
13Cancers Indications Eligible for Entry in the
NOPR
continued on next slide
14Cancers Indications Eligible for Entry in the
NOPR(continued)
15Does NOPR Apply to Oncologic PET with
Radiopharmaceuticals other than FDG?
16Facility and Patient Registration
- Register via the NOPR Web site www.cancerPETregist
ry.org - Complete Facility Registration Form
- PET facility information including Medicare
Provider Number - PET facility administrator (the individual
responsible for managing registry activities at
the facility) - Participating interpreting physician(s)
- Equipment details
- Submit Executed Business Associates Agreement
(BAA) - 50 Facility Application Fee
- 50 Processing Fee for Each Patient
- Advance payment held in escrow account
17NOPR Web Site
- Information for
- PET Facilities
- Referring Physicians
- Patients
- Blank Forms
- Register PET Facilities
- Register Patients
- PET Facility Tools
- Case Status Reports
- Account Balance
- Fund Account by Credit Card
18Pre-PET Form 5 Questions
- Reason for the PET Scan
- Cancer Site/Type
- Summary of Disease Stage
- NED, Localized, Regional, Metastatic, Unknown
- Performance Status
- Asymptomatic, Symptomatic, Bedridden
- Intended Patient Management Plan
19Pre-PET Form Specific Reason For PET
1. Check the single best match for the reason for
the PET.
- Diagnosis To determine if a suspicious lesion is
cancer - Diagnosis
- Unknown primary tumor To detect a primary tumor
site in a patient with a confirmed or strongly
suspected metastatic lesion - Paraneoplastic To detect a primary tumor site in
a patient with a presumed paraneoplastic syndrome - Initial staging of histologically confirmed,
newly diagnosed cancer - Monitoring treatment response during
chemotherapy, radiotherapy, or combined modality
therapy - Restaging after completion of therapy
- Suspected recurrence of a previously treated
cancer
20Pre-PET Form Intended Patient Management Plan
5. If PET were not available, your current
management strategy would be (select one)?
- Observation (with close follow-up)
- Additional imaging (CT, MRI) or other
non-invasive diagnostic tests - Tissue biopsy (surgical, percutaneous, or
endoscopic). - Treatment (if treatment is selected, then also
complete the following) - Treatment Goal (check one) ? Curative
? Palliative - Type(s) (check all that apply)
- ? Surgical ? Chemotherapy (including biologic
modifiers) - ? Radiation ? Other ? Supportive care
21Pre-PET Web Form
2.
42 Primary and Metastatic Sites Listed
22Pre-PET Web Form continued
23Post-PET Form 4 to 7 Questions
- Questions Customized by Specific Reason for PET
(Indication) - 4 - 7 Questions per Indication
- Most Require a Yes or No Answer
- 2 Questions are Repeated from the Pre-PET Form
- Intended Patient Management Plan
- Planned Cancer Care Provider
- Referring Physician Consent
24NOPR Workflow
PET Reviewed Reported
Clinical Actions Ongoing
Referring MD Requests PET
PET Done
Ask Patient For Consent
Post-PET Questionnaire Sent Includes Question
for Referring Physician Consent
Questionnaire Completed
Pre-PET Questionnaire
25Timeline
- Timeline available on NOPR Website.
26Billing
- Hold claims until all data is entered in the
Registry - Notify reading physicians when all data is
entered into NOPR and the PET facility has the
NOPR e-mail verification
27Timeline
No Waiting Period
Providers Bill Medicare Using Appropriate Claim
Form Codes
Hospitals Use UB/1450 Claim Form Technical Only
Non-Hospitals Use 1500 Claim Form Professional/Te
chnical/Global
28FDG-PET Procedure and Supply Codes
2006 HCPCS Code Description
78811 Tumor imaging, positron emission tomography (PET) limited area (eg, chest, head/neck)
78812 Tumor imaging, positron emission tomography (PET) skull base to mid-thigh
78813 Tumor imaging, positron emission tomography (PET) whole body
78608 Brain imaging, positron emission tomography (PET) metabolic evaluation
A9552 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries
29FDG-PET/CT Procedure and Supply Codes
2006 HCPCS Code Description
78814 Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization limited area (eg, chest, head/neck)
78815 Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization skull base to mid-thigh
78816 Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization whole body
A9552 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries
30For Carriers on 1500 Claim Form Use Modifier
2006 HCPCS Modifier Description
QR Item or service provided as routine care in a Medicare specified study or Medicare qualifying clinical trial
Modifier Use by Providers to Identify NOPR
Claims Use only with procedure, not necessary
with the radiopharmaceutical billed on the same
DOS as the procedure. CMS Transmittal 956,
5/19/06
31Hospitals ONLY on 1450 Claim Form (UB)
2006 Hospital Revenue/ICD 9 CM Codes Description
0343 Diagnostic Radiopharmaceutical
0404 PET Procedures
V70.7 Examination of participants in clinical trial
V70.7 Use in the Second Diagnosis Position FL
68 From Current CMS policy CR 3741
32A 72-year-old woman with diffuse large cell
non-Hodgkin's lymphoma is undergoing chemotherapy
with R-CHOP. PET/CT (skull-base to proximal
thigh) is requested after the second cycle of
treatment for monitoring of therapy.
Case 1
2006 Hospital Revenue Code 2006 HCPCS/ ICD 9 CM Codes Description
0404 78815 Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization skull base to mid-thigh
0343 A9552 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries
N/A 202.80 Other Lymphomas (malignant) Not otherwise specified (NOS)
33Use of PET for Treatment Monitoring under NOPR
- One potential problem may be collision of NOPR
intent with individual carrier frequency limits
for PET studies - Could lead to rejection of claim (or refusal of
Medicare Advantage plan to pre-authorize study) - Please notify NOPR staff if this occurs!
34A 67-year-old man has a history of glioblastoma
multiforme of left parietal lobe treated with
surgery, radiation therapy, and temazolamide.
Follow-up MRI demonstrates a new 8 mm focus of
contrast enhancement adjacent to the original
tumor bed. Brain PET is requested for restaging,
to distinguish recurrent tumor for radiation
necrosis.
Case 2
2006 Hospital Revenue Code 2006 HCPCS/ ICD 9 CM Codes Description
0404 78608 Brain imaging, positron emission tomography (PET) metabolic evaluation
0343 A9552 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries
N/A 191.3 Malignant neoplasm of brain, parietal lobe
35A 68-year-old woman has newly diagnosed
dermatomyositis and progressive weight loss. CT
of the chest, abdomen, and pelvis demonstrated no
evidence of malignancy. Whole-body PET/CT is
requested to detect an occult malignancy as the
cause of her paraneoplastic syndrome.
Case 3
2006 Hospital Revenue Code 2006 HCPCS/ ICD 9 CM Codes Description
0404 78816 Tumor imaging, positron emission tomography (PET) with concurrently acquired computed tomography (CT) for attenuation correction and anatomical localization whole body
0343 A9552 Fluorodeoxyglucose F-18 FDG, diagnostic, per study dose, up to 45 millicuries
N/A 710.3 Dermatomyositis
N/A 783.21 Abnormal Loss of Weight
36Advance Beneficiary Notice (ABN)
- A PET facility can ask registry patients to sign
an ABN. This decision is left up to each PET
facility. However, an ABN should not be
necessary. If patient eligibility is carefully
checked before the patient is entered into the
registry and before the PET scan is performed and
if the facility works closely with its referring
physicians to ensure that the required paperwork
is submitted in a timely fashion, there will be
no need to obtain ABNs.
37Medigap Insurance for Co-Payments
- Medigap insurance should cover the co-payment for
a registry PET scan, as for any other Medicare
covered service.
Managed Medicare Plans Medicare Advantage
- Managed Medicare plans such as Medicare Advantage
should pay any claims that would be covered by
Medicare. - Follow Pre-Authorization as required by the plan
38Will non-Medicare insurers reimburse for patients
entered in the Registry?
- No, there are no non-Medicare insurers who have
elected to reimburse for patients entered in the
registry. Patients with insurance coverage other
than Medicare, including Medicaid, are not
eligible to participate in the NOPR.
39Does NOPR Apply to Inpatients?
- Yes.
- The technical charge for a PET study on a
Medicare inpatient is not billed directly, but is
considered to be covered by the Diagnostic
Related Grouping (DRG) payment to the hospital
for that patient. - Inclusion of the patient in the NOPR is
necessary, however, for professional component
reimbursement for the PET study.
40I have registered my facility with NOPR and have
not sent any money. What do I need to do NOW to
prepare for a smooth transition?
- Download IRB Regulatory Materials Operations
Manual implement the required procedures. - Put systems in place to identify (up front) NOPR
patients and put triggers into billing systems to
hold claims (back end). If external MD reading,
ensure the reader does the same. - Meet/communicate with referring physicians
regarding required forms/timelines and set up
efficient processes prior to accepting patients. - Decide how your facility will handle ABNs for
NOPR patients. - Print patient and physician consent information
sheets for appropriate distribution. - Download and review the database instruction
manual.
41NOPR Working Group
- Chair, Bruce Hillner, MD, Virginia Commonwealth
University - Co-chair, Barry A. Siegel, MD, Washington
University - R. Edward Coleman, MD, Duke University
- Anthony Shields, MD, Wayne State University
- Statistician Dawei Liu, PhD, Brown University
- Epidemiologist Ilana Gareen, PhD, Brown
University
NOPR Operations Office American College of
Radiology 1818 Market Street, Suite
1600 Philadelphia, PA 19103 215-717-0859 800-2
27-5463 x 4859
42Endorsing Organizations Educational Contacts
- Academy of Molecular Imaging
- Sue Halliday, shalliday_at_eplushealthcare.com
- American College of Radiology
- Joy Brown, jbrown_at_phila.acr.org
- American College of Radiology Imaging Network
- Nancy Fredericks, nfredericks_at_phila.acr.org
- Barbara LeStage, Patient Advocate, bkles_at_cox.net
- American Society of Clinical Oncology
- Nancy Daly, dalyn_at_asco.org
- Society of Nuclear Medicine
- Denise Merlino, denise_at_merlinohccc.com
43Questions?
- Send questions via e-mail to pet_registry_at_phila.ac
r.org.